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A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis
The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection. Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Investigator site 6 - US0010032
Carlsbad, California, United States
Investigator Site 47 - US0010021
Palo Alto, California, United States
Investigator Site 45 - US0010108
Boca Raton, Florida, United States
Investigator site 4 - US0010110
Port Charlotte, Florida, United States
Investigator Site 39 - US0010006
Tampa, Florida, United States
Investigator Site 41 - US0010015
Kansas City, Kansas, United States
Investigator Site 46 - US0010111
Amherst, New York, United States
Investigator Site 38 - US0010003
Chapel Hill, North Carolina, United States
Investigator Site 44 - US0010077
Durham, North Carolina, United States
Investigator Site 42 - US0010019
Cleveland, Ohio, United States
Start Date
April 26, 2021
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2024
Last Updated
January 22, 2026
184
ACTUAL participants
efgartigimod PH20 SC
BIOLOGICAL
Lead Sponsor
argenx
NCT07247279
NCT06149559
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06055959